Home NDC 0338-0024-20 epinephrine
Product NDC 0338-0024
Requested package NDC 0338-0024-20
11-digit product format 003380024
Labeler code 0338
Product ID 0338-0024_cdf8a0ef-38b7-4e08-8496-942ac752ebe3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epinephrine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA218475
Marketing category NDA
Marketing start 2025-02-28
Substance EPINEPHRINE BITARTRATE
Active strength 64 ug/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base epinephrine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPINEPHRINE BITARTRATE 64 ug/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0024-20 epinephrine 20 in 1 CARTON INJECTION, SOLUTION 20 9 0338-0024-20 epinephrine 250 mL in 1 BAG INJECTION, SOLUTION 250 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0024 EPINEPHRINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 5 Current NDC, 2 package rows 20250507_60efd409-3555-4182-a68d-1cd7bc0d1bfc.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0338-0024-20 00338002420 20 BAG in 1 CARTON (0338-0024-20) / 250 mL in 1 BAG 20 bag 2025-02-28 No No Current